Medicament training device and system

ABSTRACT

In one embodiment, a medicament system configured to communicate information about a medicament device or about a use of a medicament device, or a combination thereof, to a user, is provided. The medicament system may include a medicament device including a housing, and a collateral device, wherein the collateral device may include an information detecting and/or receiving component configured to receive information from the medicament device and/or a sending component configured to send information to the medicament device, and optionally at least one of: a) a signal output component; b) a microprocessor; c) a storage medium component; and d) a power source, and wherein the medicament device may be configured to generate information detectable by the collateral device, or transmit information to the collateral device, wherein the collateral device may be configured to detect and/or receive information about the medicament device from the medicament device and provide information about the medicament device and/or a feedback about a use of the medicament device to a user of the system. The medicament device may further include a transmitter configured to communicate information and/or signals from the medicament device to the collateral device and/or a remote device, and/or receive information and/or signals from a collateral device and/or a remote device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 14/293,534 filed on Jun. 2, 2014, which is a continuation inpart of U.S. patent application Ser. No. 13/650,676 filed on Oct. 12,2012 which claims the benefit of U.S. Provisional Application No.61/620,168 filed on Apr. 4, 2012, all of which are incorporated byreference herein.

BACKGROUND

Performing a medical treatment or test on oneself carries with itcertain risks and often creates a level of anxiety for the userperforming the treatment or test. It has proven beneficial in themedical field to practice various medical techniques including drugdelivery, specifically where it relates to injections and other invasivedrug delivery means prior to delivering the medications to a patient inneed, and particularly in the case of self-administration ofmedicaments. Training devices are helpful in reducing errors and anxietyassociated with self administering medical treatment, as well asincreasing efficiency and accuracy in providing the treatment topatients. Medical devices can be intimidating to use; the fearassociated with giving oneself an injection, for example, can betraumatic. This fear is increased in persons with little or noexperience in self-administration of medications. Consequently, devicesand methods to assist in training individuals to inject themselves orotherwise self-administer medication are beneficial in decreasing orpreventing the anxiety associated with medicament delivery. Medicamentdelivery training devices allow patients to practice giving themselves afull dose in a safe and effective manner.

SUMMARY

In one embodiment, a medicament system configured to communicateinformation about a medicament device or about a use of a medicamentdevice, or a combination thereof, to a user, is provided. The medicamentsystem may include a medicament device including a housing, and acollateral device, wherein the collateral device may include aninformation detecting and/or receiving component configured to receiveinformation from the medicament device and/or a sending componentconfigured to send information to the medicament device, and optionallyat least one of: a) a signal output component; b) a microprocessor; c) astorage medium component; and d) a power source, and wherein themedicament device may be configured to generate information detectableby the collateral device, or transmit information to the collateraldevice, wherein the collateral device may be configured to detect and/orreceive information about the medicament device from the medicamentdevice and provide information about the medicament device and/or afeedback about a use of the medicament device to a user of the system.The medicament device may further include a transmitter configured tocommunicate information and/or signals from the medicament device to thecollateral device and/or a remote device, and/or receive informationand/or signals from a collateral device and/or a remote device.

In another non-limiting embodiment, a medicament system configured tocommunicate information about a medicament device or about a use of amedicament device, or a combination thereof, to a user is provided. Themedicament system includes a medicament device including a housing, themedicament device including a sensor associated therewith, a transmitterconfigured to send information from the medicament device, andoptionally at least one of: a) a signal output component; b) amicroprocessor; c) a storage medium component; and d) a power source,the medicament system including a collateral device, the collateraldevice including an information detecting and/or receiving componentconfigured to receive information produced from the sensor and/or asending component configured to send information to the medicamentdevice, a signal output component, a microprocessor, a storage mediumcomponent, and a power source, wherein the collateral device isconfigured to detect and/or receive information about the medicamentdevice from the medicament device, and/or send information to themedicament device, and/or to provide information about the medicamentdevice and/or a feedback about a use of the medicament device to a userof the system.

In yet another embodiment, a medicament system configured to communicateinformation about a medicament device or about a use of a medicamentdevice, or a combination thereof, to a user, is provided. The medicamentsystem includes a medicament device having a housing, a collateraldevice comprising a sensor, and an attachment component configured tosecure the collateral device to the medicament device. The system mayfurther include in an embodiment, a sending component configured to sendinformation to the medicament device and/or the collateral device, aninformation detecting and/or receiving component configured to receiveinformation from the medicament device about the medicament deviceand/or about a use of the medicament device. The system may furtherinclude a signal output component, a microprocessor, a storage mediumcomponent, and a power source, wherein the signal output component isconfigured to provide an output comprising information about themedicament system and/or information about a usage of the medicamentdevice or system to a user of the system.

In another embodiment, a collateral device configured to receiveinformation from and/or detect information about a medicament device isprovided. The collateral device includes a collateral device housing,and may further include a detecting and/or a receiving component,wherein the detecting and/or receiving component is configured to detectinformation about or receive information from the medicament device, asignal output component configured to provide an output to a user, apower source, a microprocessor, and a storage module, wherein thecollateral device provides a feedback to a user based on informationdetected and/or received by the detecting and/or receiving component, ina non-limiting embodiment.

In another embodiment, a method of using a collateral device to train auser of a medicament device to properly operate the medicament device todispense a dose of medicament and to provide an instruction and/or afeedback to a user of the collateral device is provided. The method mayinclude detecting and/or receiving information from a medicament device,processing information received from the medicament device, andproviding a signal output to a user based on information received andprocessed.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description briefly stated above will be rendered byreference to specific embodiments thereof that are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments and are not therefore to be considered to be limiting of itsscope, the embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a schematic of a system embodiment described herein.

FIG. 2 is a schematic of another system embodiment described herein.

FIG. 3 is a schematic of a further system embodiment described herein.

FIG. 4 is a schematic of yet another system embodiment described herein.

FIG. 5 is a schematic of a system embodiment described herein.

FIG. 6 is a schematic of a system embodiment described herein.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles andoperation of the invention, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated device, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to thoseskilled in the art to which the invention pertains.

It is important to an understanding of the present invention to notethat all technical and scientific terms used herein, unless definedherein, are intended to have the same meaning as commonly understood byone of ordinary skill in the art. The techniques employed herein arealso those that are known to one of ordinary skill in the art, unlessstated otherwise. For purposes of more clearly facilitating anunderstanding the invention as disclosed and claimed herein, thefollowing definitions are provided. It should be borne in mind that allpatents, patent applications, patent publications, technicalpublications, scientific publications, and other references referencedherein are hereby incorporated by reference in this application in orderto more fully describe the state of the art to which the presentinvention pertains.

In addition to increasing confidence in self-administration in users bypracticing with a medicament system, the inventors have identifiedadditional benefits associated with multi-sensory learning regarding amedicament system. It has been discovered that multi-sensory learningestablishes multiple pathways in separate areas in the brain andultimately results in a highly effective learning experience. However,in order to gain benefits from multi-sensory learning devices, certainrequirements must be met including but not limited to the following: thesources of stimuli must be in close proximity to one another; thesources of stimuli must be synchronous; the stimuli must be congruoussemantically, otherwise the superior colliculus (area of the brainlocated in the midbrain known for integrating multiple sources ofinformation) will segregate the stimuli instead of integrate them; andfinally, the use of extraneous materials must be limited.

With knowledge of the essential factors in multi-sensory learning andincorporation of the multi-sensory learning features into a trainingsystem, the inventors have developed a novel, cutting-edge medicamentsystem. The inventors have identified a need for a system to assistusers in administering medication or training for medicationadministration. Various modes of administration are provided by thesystem embodiments disclosed herein including parenterally administeredmedications, inhaler-based medications, among other modes ofadministration. Embodiments of the system described in greater detailbelow include applications for home use, in-office use by health careprovider (HCP) or by the patient, hospital use, and educational use fortraining medical professionals and other personnel among other potentialuses. The inventors have discovered a system for training individuals touse medical devices while improving user comfort and confidence indelivery and administration of medicament.

In addition to increasing confidence in self-administration in users bypracticing with a medicament system, the inventors have identifiedadditional benefits associated with multi-sensory learning regarding amedicament system. It has been discovered that multi-sensory learningestablishes multiple pathways in separate areas in the brain andultimately results in a highly effective learning experience. However,in order to gain benefits from multi-sensory learning devices, certainrequirements must be met including but not limited to the following: thesources of stimuli must be in close proximity to one another; thesources of stimuli must be synchronous; the stimuli must be congruoussemantically, otherwise the superior colliculus (area of the brainlocated in the midbrain known for integrating multiple sources ofinformation) will segregate the stimuli instead of integrate them; andfinally, the use of extraneous materials must be limited. With knowledgeof the essential factors in multi-sensory learning and incorporation ofthe multi-sensory learning features into a training system, theinventors have developed a novel, cutting-edge medicament system.

Exemplary embodiments of the medicament delivery training device can beimplemented to educate users on the proper operation and usage of amedicament device. The medicament system can be used to make prospectiveand current users of medicament devices feel more comfortable andconfident in self-administration (or administration to others) ofmedicaments, and can help users understand the proper steps ofmedicament delivery. Exemplary embodiments of the medicament system canbe used by a user before the user administers a medication by way of,for example, an auto-injector by way of using an actual automaticinjection device corresponding to the automatic injection trainingdevice and/or can be used as needed or desired by the user. Otherexemplary embodiments of the invention herein pertain to manualinjection devices and manual injection training devices used by theuser, respiratory inhaler trainers and respiratory inhaler drug deliverydevices, in non-limiting examples.

The medicament system takes advantage of the multisensory learningcapabilities of the human brain. As such, the medicament system providesthe means to stimulate primarily the visual, auditory and somaticsystems of the human nervous system.

Visual stimuli or feedback (visual output) can be generated mechanicallyor electronically. An example of a mechanically generated visualstimulus is a plunger moving past an inspection window in anautoinjector or prefilled syringe medicament device or a shroudextending from an injection device. An example of an electronicallygenerated visual stimulus is one or more LED's blinking, an LCD displayshowing an icon, or key steps in the process of administration beinghighlighted on a screen in the order required for proper administrationof medicament, in non-limiting examples. A visual output as disclosedherein includes but is not limited to a light, a display, a colorometricdisplay system, a change in position of the device or any other type ofvisual cue to the user of the container and/or device. The visual outputis associated with the medicament device or with the medicament trainingcontainer; therefore it may be disposed on either portion of the systemor provided in connection with the system either by a wire orwirelessly.

Additional visual outputs that may be incorporated into the systemherein may include display devices having one or more layers of materialhaving a light transmission region, a unit of information to behighlighted, and a light blocking region; and a backlight unit having aflexible, planar waveguide body, a light source configured to directlight into the waveguide body, and at least one light directorassociated with a portion of the waveguide body so as to direct lighttransversely to a plane of the waveguide body. The directed lighttravels through the light transmission region, and the directed light isdirected toward the unit of information to be highlighted as provided inInternational Application No. PCT/US 11/26976 and U.S. National Stageapplication Ser. No. 13/582,560 which claim the benefit of U.S.Provisional Application Ser. No. 61/310,081, which are incorporated byreference in their entireties herein. The unit or units of informationto be highlighted may include the stepwise instructions foradministering the medicament to a user and may also provide the durationof each step by way of highlighting each step for a predetermined amountof time such that the user can follow the precise timing of each step inthe sequence.

Auditory stimuli or feedback (audio output) can also be generatedmechanically or electronically. An example of a mechanically generatedauditory stimulus is the “click” that can be heard if two parts of adevice interlock. An example of an electronically generated auditorystimulus is a beeper or a speaker that plays spoken instructions. Anaudio output as disclosed herein includes but is not limited to music, asound, a beep, a series of beeps music or sounds, a mechanical soundincluding clicking, a sound replication of operation or behavior of adrug delivery device containing medicament. These auditory stimuli, suchas two parts of a device interlocking can be picked up by a microphoneof the system. The system can then identify whether or not the devicewas used correctly (i.e., whether a step was performed correctly or inthe correct order, for example). A combination of both visual andauditory output may include a video tutorial providing instructions to auser on proper administration of the medicament or use of the trainingdevice, for example.

Somatic stimuli or feedback, also called somatosensory stimuli ortactile feedback, is typically generated mechanically. In a typicalembodiment of the medicament system, there are a large number of somaticstimuli, particularly with reference to the medicament device, such asactuation forces, abrasion resistance, frictional forces, springcompression, the feel of a click if two parts interlocking, surfacetexture, vibrations, weight sensation, and any other similar stimuli orfeedback known to those of skill in the art.

A “predetermined value” as used herein, for example, includes but is notlimited to a value or range of values relating to an event involving useor operation of the device. These may include, but are not limited tothresholds, ceilings, baselines or range values that are desired orundesired for a particular event. Examples of predetermined valuesinclude, but are not limited to, a predetermined orientation value,predetermined time value, or a predetermined contact value, in additionto other predetermined values described herein refers to a value that isused as a reference value in relation to a value, signal, or indicationthat is detected by, for example, a sensor of the medicament device.Predetermined value may include an optimal value, or a sub-optimalvalue, or any value there between, or any combination thereof. The term“value” as used herein, may refer to a specific value or a range ofvalues.

In one example, a predetermined perpendicularity value may include a 90degree angle between the device and a target region for the medicamentdevice, an additional predetermined perpendicularity value may include a10 degree angle between the device and a target region for the device.At either predetermined perpendicularity value, or at any value therebetween, a signal output component may be initiated. The signal outputcomponent may therefore be an error message or a congratulatory message,for example. This signal output component may be initiated from themedicament device and/or the medicament training container.

The term “condition” as used herein includes but is not limited to oneor a combination of a user input, a status of the medicament device orthe medicament training container, anything that is sensed by the deviceor container, correct or incorrect stepwise activities, usage of thedevice over time, among other conditions.

The term “error condition” as used herein includes but is not limited toone or a combination of a condition pertaining to a mistake by the userin using the device, whether the mistake is incorrect positioning orcontact between the device and the user, or whether the mistake is anout of order step, a step that exceeds or fails to meet predeterminedtime value (such as an undue pause during or between steps, orinsufficient time for conducting a step or transition between steps).Error conditions may also include errors of the device itself or of thecontainer, including low or lack of power or failure to operate asintended.

The term reconstituted as used herein includes a return of thecomponents to their original state. For example, following use of themedicament device, once the device is in a post-delivery state (or posttraining state), it can be reset for subsequent use. As part of theresetting of the device from a post-delivery (or post-training) state toa pre-delivery (or pre-training) state, the signal output componentsincluding audio, visual, olfactory, gustatory, and tactile are alsoreset back to their original states, or reconstituted, such that asubsequent training or medicament delivery can be performed with thedevice. The term reconstituted may also include return of the medicamenttraining container to its original state and may include a return of thestepwise instructions to the first step in the sequence or a replacementof the medicament device within the medicament training container inpreparation for a subsequent medicament delivery or training, forexample.

The term “medicament device” as used herein includes but is not limitedto a training medicament device or a drug delivery medicament device,including an injection device such as an auto-injector and/or trainer,an inhaler device and/or respiratory trainer, a bolus injector, a nasalinhaler device, a needless injector, a transdermal patch, an ampoule, amedicine container, a medicine package, a vial, a metered-dose inhaler,a dry powder inhaler, a prefilled syringe, among other medicamentdevices known to one of ordinary skill in the art. In non-limitingembodiments, the medicament device may include a housing, and thehousing may include a mechanism having one or more mechanical componentsassociated with the housing that move relative to one another to producea visual, a tactile and/or an audible output detectable by a detectingcomponent of the collateral device, for example.

The term “fluid” as used herein may include any type of fluid, includingbut not limited to liquid or gas. The fluid may specifically include aliquid, powder or aerosol medicament, air flowing to or from the user,or liquid coming from the user, in some non-limiting embodiments.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a,” “an,” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise theseterms do not denote a limitation of quantity, but rather denote thepresence of at least one of the referenced item. For example “a sensor”may denote the presence of at least one sensor; however, multiplesensors may be contemplated unless otherwise specifically stated.Furthermore, to the extent that the terms “including,” “includes,”“having,” “has,” “with,” or variants thereof are used in either thedetailed description and/or the claims, such terms are intended to beinclusive in a manner similar to the term “comprising.” Moreover, unlessspecifically stated, any use of the terms first, second, etc., does notdenote any order, quantity or importance, but rather the terms first,second, etc., are used to distinguish one element from another.

The term “sensor” or “sensors” as used herein may include but are notlimited to, light sensors, fluid flow rate sensors, strain gaugesensors, temperature sensors, pressure sensors, tilt sensors, forcesensors, level sensors, contact sensors, photoelectric sensors, magneticsensors, ultrasonic sensors, electrochemical sensors, accelerationsensors, moisture sensors, humidity sensors, speed sensors, inductivesensors, capacitive sensors, and orientation sensors. Some of thesesensors may require a supply of voltage. The medicament system mayinclude one or more of the sensors described herein, for example, acontact sensor may be used to detect removal or placement of the smartdevice onto the medicament device, for example, or removal or placementof the medicament device onto the user, in another example. In a furtherexample, two or more contact sensors, more preferably thee contactsensors may be used to detect perpendicularity of the medicament devicerelative to a target area of a patient. An example of an inductivesensor includes material embedded in or associated with the medicamentdevice, wherein said embedded or associated material proportionallychanges the magnetic field of the inductive sensor which may beassociated with or embedded in the smart device, in one non-limitingexample, depending on its distance away from the inductive sensor. Thesensor then outputs a variable electrical signal based on the distancebetween the embedded or associated material and the inductive sensor.

The tactile or vibration component may include a vibration system, whichprovides a vibratory sensation. In one embodiment, this vibrator systemmay include a motor, in a non-limiting example a small DC motor, a gearand a weight. The weight may be mounted off-center on the gear, suchthat when the motor spins, the gear/weight combination at 100 to 150 rpmfor example, the off-center mounting creates a vibration. In anotherembodiment, a linear transducer may be used. In a further example, aneccentric motor can be used to provide an oscillation or vibration.

The terms “medicament training system” and “medicament system” may beused interchangeably herein. The medicament training system ormedicament system may be used to train a user to use a medicamentdelivery device during, before, or after use of the medicament deliverydevice. A “medicament delivery device” refers to a medicament devicethat may be used to deliver medication to a user.

The term “medicament device” as used herein may include a trainingdevice or a medicament delivery device, or a combination thereof. In onenon-limiting embodiment, a medicament device may be used to both train auser to use the medicament device and also deliver medicament to theuser. In a particular non-limiting embodiment, a medicament device mayinclude different modes, wherein one mode may be used for training only,another may be used for medicament delivery only, and a further mode maybe used for training or guidance during medicament delivery, forexample. The medicament device may include medicament in somenon-limiting embodiments. In other non-limiting embodiments, themedicament device may not include medicament.

The term “associated” or “association,” as used herein, includes but isnot limited to direct and indirect attachment, adjacent to, in contactwith, partially or fully attached to, and/or in close proximitytherewith. The term “in conjunction with” as used herein includes but isnot limited to synchronously or near synchronous timing, the phrase mayalso include the timing of outputs, where one output directly followsanother output.

Any of the abovementioned outputs by the signal output component can bepresented along with or in conjunction with any of the other outputs ofthe device. For example, a visual and an audio stimulation or feedbackmay occur at the same time or within the same step of the training toenhance training of the user. Furthermore, the inventors have discoveredthat a combination of mechanical feedback (kinesthetic) and electronicfeedback enhances the learning experience of a user when using themedicament training system.

Embodiments of the medicament system herein may be provided whereinvarious components of the system may be incorporated into either one ofa medicament device or a collateral device, or both. Some components ofthe system may be in the medicament device and other components of thesystem may be in the collateral device, in a non-limiting embodiment.

In one embodiment, a medicament system configured to communicateinformation about a medicament device or about a use of a medicamentdevice, or a combination thereof, to a user, is provided. The medicamentsystem may include a medicament device including a housing, and acollateral device, wherein the collateral device may include aninformation detecting and/or receiving component configured to receiveinformation from the medicament device and/or a sending componentconfigured to send information to the medicament device, and optionallyat least one of: a) a signal output component; b) a microprocessor; c) astorage medium component; and d) a power source, and wherein themedicament device may be configured to generate information detectableby the collateral device, or transmit information to the collateraldevice, wherein the collateral device may be configured to detect and/orreceive information about the medicament device from the medicamentdevice and provide information about the medicament device and/or afeedback about a use of the medicament device to a user of the system.The medicament device may further include a transmitter configured tocommunicate information and/or signals from the medicament device to thecollateral device and/or a remote device, and/or receive informationand/or signals from a collateral device and/or a remote device.

In a further embodiment, the collateral device of the system may be ableto receive or obtain information from a remote source as well as sendinformation to a remote source such as the Internet, a database, atelephone, a computer, or other source, in non-limiting embodiments. Theinformation and/or signal sent or received may include information aboutthe medicament device, a user, a medicament, a use of the medicamentdevice, instructions for using the medicament device or the medicament,a physician or other healthcare provider, a hospital, a pharmacy, innon-limiting examples. In a non-limiting embodiment, the collateraldevice may include a Smartphone which will be described in more detailbelow.

The signal output component may be configured to output an audio, avisual, a tactile, a gustatory, or an olfactory signal, or a combinationthereof, to the user, in non-limiting embodiments.

In another embodiment, the collateral device includes the power source.In another embodiment, the information detecting component may detectmovement of the medicament device or components thereof. In someembodiments, the medicament device may include one or more mechanicalparts or components that may move relative to one another. The detectingcomponent may detect movement of the medicament device and/or movementof the mechanical components of the medicament device. The informationdetected may be provided to a microprocessor and a signal may beprovided to a user. Furthermore, the information detected may be storedon the storage medium component. In one non-limiting embodiment, thedetecting component may include a camera and/or a motion sensor.

In another embodiment, the receiving component may be configured toreceive a signal from the medicament device. The signal may provideinformation about the medicament device, a medicament associated withthe device and/or a use of the medicament device. In a non-limitingembodiment, the receiving component includes a microphone, and thesignal received from the medicament device is an audible signal, whereinthe microphone is configured to receive the audible signal from themedicament device and/or a mechanical sound produced by a mechanismincluding one or more mechanical components associated with the housingof the medicament device during use of the medicament device.

In a further embodiment, the medicament device may communicatinglyconnect to the collateral device via a wired or a wireless connection,wherein said connection provides a communication of power and/orinformation between the medicament device and the collateral device. Insome non-limiting embodiments, communication between the medicamentdevice and the collateral device includes one way communication of powerand/or information from the collateral device to the medicament device,or from the medicament device to the collateral device, and two-waycommunication of power and/or information to and from the medicament andcollateral devices.

In one non-limiting embodiment, the medicament system is providedwherein the wireless connection includes a Bluetooth® and/or an RFID(Radio Frequency Identification) technology. In a further embodiment,the RFID technology includes an RFID transponder and an RFID reader. Inanother non-limiting embodiment, the RFID transponder is associated withthe collateral device and the RFID reader is associated with themedicament device, the medicament device includes the power source, suchthat the RFID reader of the medicament device can power the collateraldevice by way of the RFID transponder.

The RFID transponders, or tags, described herein may be active,semi-active or passive and may include a microchip and an antenna. Theactive and semi-active RFID transponders may additionally include abattery, in a non-limiting example.

In another non-limiting embodiment, the RFID transponder is associatedwith the medicament device and the RFID reader is associated with thecollateral device wherein the collateral device includes the powersource, and wherein the RFID reader of the collateral device powers themedicament device by way of the RFID transponder.

In a further embodiment, the medicament system is provided wherein oneof the medicament device or the collateral device comprises a uniqueidentification component. The unique identification component mayinclude, in non-limiting embodiments, information about a medicament,the medicament device, use of the medicament device, or informationabout the collateral device, or other information know to one ofordinary skill in the art. The other of the medicament device or thecollateral device may include a unique identification reader, whereinthe unique identification reader is configured to read information on orassociated with the unique identification component, in an embodiment.In one non-limiting embodiment, the unique identification component mayinclude a bar code and the unique identification reader may include abar code reader.

In another embodiment, the medicament system is provided wherein thecollateral device includes or is configured to receive pre-programmedinformation. The pre-programmed information may include informationabout a medicament device, in a non-limiting embodiment. Thepre-programmed information may include information about a medicament, auser, a healthcare provider, a healthcare facility, or otherinformation, in other non-limiting embodiments.

In a further embodiment, the medicament system is provided wherein thecollateral device is configured to download or receive information froma database, the Internet, and/or another device. The information mayinclude information about a medicament, a medicament device includinginstructions for use, contraindication of medicaments, information abouta user, medicament dosage information, storage information, prescribingphysician information, pharmacy information, manufacturer information,warning information, recall information, in non-limiting embodiments,environmental data, geographical information, time zone information, MET(meteorological) data, storage information, supply chain information,transit data, and/or temperature data.

In a non-limiting embodiment, the collateral device may include thesignal output component, the microprocessor, the storage mediumcomponent and the power source. In another embodiment, the signal outputcomponent may include a speaker, a display, a light, a vibrationcomponent, a smell-emitting component, or a temperature-changingcomponent, or a combination thereof.

In a further embodiment, the medicament system is provided wherein thecollateral device may be configured to detect a condition of themedicament device in response to information received by the informationdetecting and/or receiving component and/or information received via thewired or wireless connection with the medicament device. In a furtherembodiment, the condition may include an error condition, a correctusage of the system, and/or an input sensed by the system. In anotherembodiment, the medicament system may provide a feedback to a user ofthe system via the signal output component. This feedback may be basedon a condition detected, in a non-limiting embodiment.

In another embodiment, the medicament system may provide instructionsfor using the medicament device in a sequence of steps, wherein themicroprocessor is configured to control a provision of the instructionsfor using the medicament device to the user in the sequence of stepsand/or to provide an instruction to the user based on informationdetected and/or received by the information detecting and/or receivingcomponent of the collateral device.

In a further embodiment, the system may include a sensor associated withthe medicament device, wherein the sensor may be configured to detect acondition of the medicament device. Information about the conditiondetected by the sensor may be communicated to the collateral deviceand/or to a user from the medicament device, in an embodiment. Theinformation that is communicated to the collateral device may further beprovided from the collateral device to the user in a non-limitingembodiment.

In another non-limiting embodiment, a medicament system configured tocommunicate information about a medicament device or about a use of amedicament device, or a combination thereof, to a user is provided. Themedicament system includes a medicament device including a housing, themedicament device including a sensor associated therewith, a transmitterconfigured to send information from the medicament device, andoptionally at least one of: a) a signal output component; b) amicroprocessor; c) a storage medium component; and d) a power source,the medicament system including a collateral device, the collateraldevice including an information detecting and/or receiving componentconfigured to receive information produced from the sensor and/or asending component configured to send information to the medicamentdevice, a signal output component, a microprocessor, a storage mediumcomponent, and a power source, wherein the collateral device isconfigured to detect and/or receive information about the medicamentdevice from the medicament device, and/or send information to themedicament device, and/or to provide information about the medicamentdevice and/or a feedback about a use of the medicament device to a userof the system.

In another embodiment, the medicament system is provided wherein thecollateral device includes the microprocessor, the storage mediumcomponent, the power source, and the signal output component. In afurther embodiment of the medicament system, the medicament device maycommunicatingly connect to the collateral device via a wired and/or awireless connection, wherein said connection provides a communication ofpower and/or information between the medicament device and thecollateral device. A communication of power or information can be eitherone way or two-way. One way communication may occur from the collateraldevice to the medicament device or vice versa, and two-way communicationbetween the collateral device and the medicament device may occur, innon-limiting embodiments. Communication of power may be from thecollateral device to the medicament device in one non-limitingembodiment, from the medicament device to collateral device in anothernon-limiting embodiment. As aforementioned, the communication may be oneway communication or two way communication between the components of thesystem. In one particular non-limiting embodiment, informationcommunication is communicated from the medicament device to thecollateral device, and power may be communicated from the collateraldevice to the medicament device.

In a further embodiment, the medicament system is provided wherein thewireless connection includes a Bluetooth® and/or an RFID technology. Ina further embodiment, the RFID technology comprises an RFID transponderand an RFID reader. In still a further embodiment, the RFID transponderis associated with the collateral device and the RFID reader isassociated with the medicament device, the medicament device includingthe power source, such that the RFID reader of the medicament device canpower the collateral device by way of the RFID transponder.

In an alternative embodiment, the RFID transponder may be associatedwith the medicament device and the RFID reader may be associated withthe collateral device, wherein the collateral device includes the powersource, and wherein the RFID reader of the collateral device powers themedicament device by way of the RFID transponder.

In a further embodiment, the medicament system is provided wherein oneof the medicament device or the collateral device includes a uniqueidentification component, the unique identification component includinginformation. In non-limiting embodiments, the information may includeinformation about a medicament, the medicament device, use of themedicament device, or information about the collateral device. In anon-limiting embodiment, the other of the medicament device or thecollateral device includes a unique identification reader, said uniqueidentification reader being configured to read information on the uniqueidentification component.

In a further embodiment, the unique identification component includes abar code and the unique identification reader includes a bar codereader. In a further embodiment, the medicament system may be providedwherein the collateral device includes pre-programmed information. Thepre-programmed information may include information about one or moremedicament devices, about one or more medicaments, about one or moreusers, or other information know to one skilled in the art.

In a further embodiment, the medicament system may be provided whereinthe collateral device is configured to download or receive informationfrom a database, the Internet, and/or another device, the informationmay include information about one or more medicaments, one or moremedicament devices including instructions for use, contraindication ofmedicaments, information about one or more users, medicament dosageinformation, storage information, prescribing physician information,pharmacy information, manufacturer information, warning information,recall information, environmental data, geographical information, timezone information, MET (meteorological) data, storage information, supplychain information, transit data, and/or temperature data, innon-limiting embodiments.

As aforementioned, the signal output component of the medicament systemmay include a speaker, a display, a light, a vibration component, asmell-emitting component, or a temperature-changing component, or acombination thereof in non limiting embodiments. In another embodimentof the medicament system, the medicament device may include a mechanismincluding one or more mechanical components associated with the housingthat move relative to one another to produce a visual, a tactile and/oran audible output detectable by the detecting component. In a furtherembodiment of the system, the collateral device may be configured todetect a condition of the medicament device in response to informationreceived by the information detecting and/or receiving component and/orinformation received via the wired and/or wireless connection with themedicament device.

In a further embodiment the medicament system is provided wherein thecondition includes an error condition, a correct usage of the system,and/or an input sensed by the system. In still a further embodiment, thesystem may provide a feedback to a user of the system via the signaloutput component based on the condition detected. In another embodiment,the system may provide instructions for using the medicament device in asequence of steps, and the microprocessor may be configured to control aprovision of the instructions for using the medicament device to theuser in the sequence of steps and/or to provide an instruction to theuser based on information produced from the sensor of the medicamentdevice.

In yet another embodiment, a medicament system configured to communicateinformation about a medicament device or about a use of a medicamentdevice, or a combination thereof, to a user, is provided. The medicamentsystem includes a medicament device having a housing, a collateraldevice comprising a sensor, and an attachment component configured tosecure the collateral device to the medicament device. The system mayfurther include in an embodiment, a sending component configured to sendinformation to the medicament device and/or the collateral device, aninformation detecting and/or receiving component configured to receiveinformation from the medicament device about the medicament deviceand/or about a use of the medicament device. In embodiments of thesystem in which the collateral device is attached or secured to themedicament device, the collateral device may not require an informationdetecting and/or receiving component configured to receive informationfrom the medicament device as the collateral device will sense thecondition of the medicament device by virtue of the attachment innon-limiting embodiments. The system may further include a signal outputcomponent, a microprocessor, a storage medium component, and a powersource, wherein the signal output component is configured to provide anoutput comprising information about the medicament system and/orinformation about a usage of the medicament device or system to a userof the system.

In a further embodiment the medicament system is provided wherein themedicament device includes the microprocessor, the storage mediumcomponent, the signal output component, and the power source. In still afurther embodiment, the medicament device may communicatingly connect tothe collateral device via a wired and/or a wireless connection, whereinsaid connection provides a communication or transmission of power and/orinformation between the medicament device and the collateral device. Inone non-limiting embodiment, the wireless connection may be short-rangewireless connection, such as Bluetooth® connection in one non-limitingexample. In a non-limiting embodiment, where a Bluetooth® connection isused a power source may be provided in both the medicament device andthe collateral device. The power source may include a battery, in onenon-limiting example.

In a further embodiment, the wireless connection may include aBluetooth® and/or an RFID technology. The RFID technology may include anRFID transponder and an RFID reader as described above, and thelocations of and associations between the RFID transponder and readermay be provided as described above in regard to the other embodimentsdisclosed herein.

Furthermore, the medicament system embodiment may further include aunique identification component and unique identification reader whereinone of the medicament device or the collateral device includes a uniqueidentification component, the unique identification component includinginformation about a medicament, the medicament device, use of themedicament device, or information about the collateral device, innon-limiting embodiments. The other of the medicament device or thecollateral device may include a unique identification reader, saidunique identification reader being configured to read information on orassociated with the unique identification component. In a furthernon-limiting embodiment, the unique identification component is a barcode and the unique identification reader is a bar code reader.

In a non-limiting embodiment of the medicament system, the collateraldevice may include the microprocessor and the storage module, thecollateral device including pre-programmed information about one or moremedicament devices and/or instructions for use for one or moremedicament device and/or medicaments associated therewith, for example.In a further embodiment, the collateral device may be configured todownload or receive information from a database, the Internet, and/oranother device, the information may include information about one ormore medicaments, one or more medicament devices including instructionsfor use, contraindication of medicaments, information about one or moreusers, medicament dosage information, storage information, prescribingphysician information, pharmacy information, manufacturer information,warning information, recall information in non-limiting embodiments,environmental data, geographical information, time zone information, MET(meteorological) data, storage information, supply chain information,transit data, and/or temperature data. Such temperature data mayinclude, in embodiments in which the medicament device includesmedicament, what temperature the medicament has been kept at and/or areport of temperatures that the medicament device and/or medicament hasbeen subjected to from the manufacturer to the user, for example. Othertemperature data may include temperature data indicating required orsuggested storage temperatures for medicaments and/or medicamentdevices.

In still a further embodiment, the signal output component of themedicament system may include a speaker, a display, a light, a vibrationcomponent, a smell-emitting component, or a temperature-changingcomponent, or a combination thereof.

In another embodiment of the medicament system, the medicament devicemay include a mechanism including one or more mechanical componentsassociated with the housing that move relative to one another to producea visual, a tactile and/or an audible output detectable by the detectingcomponent. In one non-limiting example, wherein the medicament deviceincludes a respiratory device or trainer and specifically a metered doseinhaler, for example, the one or more mechanical components of themedicament device may include the components of the metered dose inhalerhousing that move relative to one another when the inhaler is actuated.

In a further embodiment of the medicament system, the collateral devicemay be configured to detect a condition of the medicament device inresponse to information received by the information detecting and/orreceiving component and/or information received via the wired and/orwireless connection with the medicament device. In one non-limitingexample, the collateral device may detect movement of the components ofthe medicament device by way of a camera, for example, such as detectingthe movement of the mechanical components of a metered dose inhalerdevice when the metered dose inhaler device is actuated, for example.

In a further embodiment, the condition detected may include an errorcondition, a correct usage of the system, and/or an input sensed by thesystem. In still a further embodiment, the system may provide a feedbackto a user of the system via the signal output component. In someembodiments, this feedback may be based on the condition detected.

In still a further embodiment, the system may provide instructions forusing the medicament device in a sequence of steps, wherein themicroprocessor is configured to control a provision of the instructionsfor using the medicament device to the user in the sequence of stepsand/or to provide an instruction to the user based on informationreceived from the sensor of the medicament device.

In a further embodiment, the attachment component may include a hook, aclip, an adhesive, a holder which may be contoured to receive themedicament device in a non-limiting embodiment, a magnet, or acombination thereof, or any other type of attachment component known toone of ordinary skill in the art. In a non-limiting embodiment, theattachment component may be attached to one of the medicament device orthe collateral device, and configured to attach the medicament device orthe collateral device to the other of the medicament device or thecollateral device. For example, the attachment component may be affixedto the collateral device and configure to attach the collateral deviceto the medicament device, in another non-limiting example, theattachment component may be affixed to the medicament device, and beconfigured to attach the medicament device to the collateral device. Ina further non-limiting example, the attachment component may be acomponent separate from the medicament device and the collateral device,but may be configure to attach to both of the medicament device and thecollateral device.

In the embodiments provided herein, the medicament system embodimentsmay further comprise a control interface, wherein the control interfacemay include a responsive member reactive to user input. The controlinterface may be associated with the medicament device and/or thecollateral device in non-limiting embodiments.

Furthermore, as aforementioned herein, the medicament device embodimentsdescribed herein may include a medicament training device, a medicamentdelivery device, or a combination thereof.

In another embodiment, a collateral device configured to receiveinformation from and/or detect information about a medicament device isprovided. The collateral device includes a collateral device housing,and may further include a detecting and/or a receiving component,wherein the detecting and/or receiving component is configured to detectinformation about or receive information from the medicament device, asignal output component configured to provide an output to a user, apower source, a microprocessor, and a storage module, wherein thecollateral device provides a feedback to a user based on informationdetected and/or received by the detecting and/or receiving component, ina non-limiting embodiment.

In a further embodiment, the collateral device may include a sensor. Thesensor may be associated with the collateral device housing, in oneembodiment. The sensor may include a proximity sensor, aperpendicularity sensor, a contact sensor, a temperature sensor, amotion sensor, a light sensor, a fluid flow rate sensor, a strain gaugesensor, a pressure sensor, a tilt sensor, a force sensor, a levelsensor, a photoelectric sensor, a magnetic sensor, an ultrasonic sensor,an electrochemical sensor, an acceleration sensor, a moisture sensor, ahumidity sensor, a speed sensor, an inductive sensor, a capacitivesensor, or an orientation sensor, or a combination thereof, in anon-limiting embodiment.

In a further embodiment, the collateral device is provided wherein thestorage module includes pre-programmed information. The pre-programmedinformation may include information about a medicament device and/orinstructions for use for a medicament device and/or a medicamentassociated therewith, in a non-limiting example. The collateral devicemay be further configured to receive or download information about amedicament, a medicament device, and/or a user from the Internet, fromanother device, and/or from a database, wherein the information can bereceived or downloaded via a wired and/or a wireless connection.

In still a further embodiment, the collateral device may be configuredto provide instructions and/or a feedback to the user via the signaloutput component. In another embodiment, the collateral device may beconfigured to communicatingly connect to the medicament device via awired and/or a wireless connection to provide communication ortransmission of power and/or communication of information between thecollateral device and the medicament device.

A communication of power or information can be either one way ortwo-way. One way communication may occur from the collateral device tothe medicament device or vice versa, and two-way communication betweenthe collateral device and the medicament device may occur, innon-limiting embodiments. Communication (or transmission) of power maybe from the collateral device to the medicament device in onenon-limiting embodiment, from the medicament device to collateral devicein another non-limiting embodiment. As aforementioned, the communicationmay be one way communication or two way communication between thecomponents of the system. In one particular non-limiting embodiment,information communication is communicated from the medicament device tothe collateral device, and power may be communicated from the collateraldevice to the medicament device.

As described herein, the wireless connection may include a Bluetooth® oran RFID connection. The collateral device may further include a uniqueidentification reader, in non-limiting embodiments, the uniqueidentification reader may be configured to read information on a uniqueidentification component associated with a medicament device or amedicament container, for example. The unique identification reader mayinclude a bar code reader and the unique identification component mayinclude a bar code in non-limiting embodiments.

In a further embodiment, the collateral device may be configured tocommunicate with, a medicament delivery device, a medicament trainingdevice, or a combination thereof. The collateral device may communicatewith the medicament device(s) by receiving and/or sending information,receiving and/or sending signal(s), receiving and/or sending power,etc., in non-limiting examples.

In a further embodiment, the signal output component of the collateraldevice may include a speaker, a display, a light, a vibration component,a smell-emitting component, or a temperature-changing component, or acombination thereof as aforementioned herein.

In an embodiment, the collateral device may associate with a medicamentdevice that includes a mechanism including one or more mechanicalcomponents associated with the housing of the medicament device, thatmove relative to one another to produce a visual, a tactile and/or anaudible output detectable by the detecting component of the collateraldevice. The collateral device may be configured to detect a condition ofthe medicament device. This detection may be in response to informationreceived by the information detecting and/or receiving component and/orinformation received via a wired and/or a wireless connection with themedicament device, in a non-limiting embodiment.

In a further non-limiting embodiment, the condition detected may includean error condition, a correct usage of the system, and/or an inputsensed by the system. The collateral device may provide a feedback to auser of the system via the signal output component based on thecondition of the medicament device detected, in a non-limitingembodiment. In a further embodiment, the collateral device may provideinstructions for using the medicament device in a sequence of steps, andwherein the microprocessor is configured to control a provision of theinstructions for using the medicament device to the user in the sequenceof steps and/or to provide an instruction to the user based oninformation produced by or detected by the sensor of the medicamentdevice. Error conditions may include, in non-limiting examples, puttingcap back on a device, an out of sequence operation of a device, a wetinjection, and not holding at 90 degrees when required.

In a further non-limiting embodiment, the collateral device may includean attachment component configured to attach the collateral device tothe medicament device. In still a further embodiment, the attachmentcomponent may include a hook, a clip, an adhesive, a holder which may becontoured to receive a medicament device in a non-limiting embodiment, amagnet, or a combination thereof, in non-limiting examples. In anotherembodiment, the collateral device may include a control interface; thecontrol interface may include a responsive member reactive to a userinput. In still a further non-limiting embodiment, the informationdetecting and/or receiving component of the collateral device mayinclude a camera and/or a microphone.

In another embodiment, a method of using a collateral device to train auser of a medicament device to properly operate the medicament device todispense a dose of medicament and to provide an instruction and/or afeedback to a user of the collateral device is provided. The method mayinclude detecting and/or receiving information from a medicament device,processing information received from the medicament device, andproviding a signal output to a user based on information received andprocessed.

In a further embodiment, the method may include providing instructionand/or information related to a medicament device, a medicament, and/ora user to a user, wherein the instruction and/or information is storedon a storage module associated with the collateral device, in anon-limiting embodiment. The method may further include providinginstruction and/or information related to a medicament device, amedicament, and/or a user to a user, wherein the instruction and/orinformation is received by the collateral device via a wired and/or awireless connection, in a non-limiting embodiment.

In still a further embodiment, the method may include electronicallyreading information from a unique identification component associatedwith the medicament device and/or a medicament, wherein the informationis output to a user.

In another embodiment, a collateral device configured to receiveinformation from and/or detect information about a medicament device isprovided. The collateral device includes a collateral device housing, asensor associated with the housing; and an attachment componentassociated with the housing, wherein the attachment component isconfigured to attach the collateral device to the medicament device. Ina further embodiment, the collateral device may include a signal outputcomponent configured to provide an output to a user, the output mayinclude information about the medicament device, information about a useof the medicament device, information about a user of the collateraldevice, and/or information about a medicament, in non-limitingembodiments.

In the embodiments described herein, the collateral device may include aSmartphone, a computer, a PDA, or the like. These devices may includethe microprocessor, information detecting component and receivingcomponent, signal output component, storage medium, power source, or acombination thereof, such that a signal or information from a medicamentdevice can be received by a Smartphone device, in a non-limitingexample, and the Smartphone may provide the feedback or output to theuser based on the information or signal received. A display of theSmartphone may be beneficial to provide feedback to a user based oninformation received from the medicament device or received from aremote source such as the Internet, a database, another phone, or aremote computer, in non-limiting examples. In these non-limitingembodiments, it is beneficial to take advantage of the componentsalready existing in a Smartphone (or other similar device), to providetraining or guidance to a user during use of the medicament device.

Embodiments of the system and medical device described herein mayinclude sensors to provide users with an active learning experience. Ifan error is made in the training sequences, patients are notifiedthrough spoken instructions and taught how to overcome the error innon-limiting embodiments. If the user makes a mistake, in a non-limitingembodiment, the training injector may provide spoken guidance andencouragement to help establish synchronous motor skills to preventerrors in the future.

In another non-limiting embodiment, the wireless communication betweenthe medicament device and the collateral device may include RadioFrequency Identification technology, for example. If the devicescommunicate by way of RFID, either device may include the power source,and the device without the power source can be powered by the devicewith the power source. In a non-limiting example, the collateral devicemay include a power source, and the medicament device may not include apower source. In this example, the collateral device may include an RFIDreader and the medicament device may include an RFID transponder,wherein the RFID transponder may be powered by the RFID reader.

In a non-limiting embodiment, the collateral device may be preprogrammedto interact with various configurations of medicament devices.Medicament devices may include inhalation devices or inhalation trainingdevices, injection devices including autoinjectors, pre-filled syringesor any other devices for parenteral administration of medicament (orrelated training thereof), devices including medicament bottles or tubeshousing medicament (such as, for example, a pill bottle containingcapsules or tablets or a vial containing medicament in non-limitingexamples). The collateral device can be configured to associate with oneor more medicament devices and one or more medicament trainingcontainers, in non-limiting embodiments. Information can be communicatedbetween devices of the system by means known in the art, communicationmay occur between the medicament device and the collateral device andoptionally between the medicament device and/or the collateral deviceand a remote device.

Information communicated between devices may include, for example,compliance information including information about the usage of thesystem or device. Additional information may include previous uses ofthe medicament device and/or system, correct and incorrect usage of thedevice and/or system as well as instructions for use of variousmedicament devices, contraindications related to various medicamentdevices and various medicaments, possible medicament interactions,safety information and storage information, reminders or timersidentifying next scheduled administration of medicament, dosageinformation, volume and/or strength of medicament, other instructionsregarding medicament including, but not limited to compliance to therapyor treatment, warnings, and any other instructions, among otherinformation typically associated with medicaments and medicamentdevices. Information may further be communicated between the collateraldevice and a remote device, such as, for example, a Smartphone, acomputer, a database, a PDA, a digital or analog watch, other remotedevice, or other information receiving device. Information communicatedfrom the collateral device may include information about a use of themedicament device, in a non-limiting embodiment. The remote device maybe adapted to receive the information and/or process the information andprovide a feedback to a user of the system or an additional user such asa medical professional, a family member, or other person or entity.Information may be communicated between the collateral device and one ormore remote devices, between the collateral device and the medicamentdevice, or between the medicament system or medicament training deviceand one or more remote devices. Information can be communicated, asdescribed herein, by way of wired and/or wireless communication.Feedback provided by the remote device may include training information,information about a correct or incorrect usage of the device, system, ormedicament, error correction information, positive feedback, remindersregarding using the device, system, or taking a medicament. Otherreminders may be provided by the remote device including, but notlimited to reminders to make an appointment with a physician, remindersto refill a prescription, reminders to take a medicament, reminders totrain using the medicament device, collateral device and/or system,among other reminders.

Non-limiting examples of collateral devices described herein may includea Smartphone, a non-electronic device, other types of electronic devicesincluding, but not limited to, a computer, a PDA, a tablet, a digital oranalog watch, for example.

In additional embodiments of the systems and devices provided herein, anintermediate collateral device may be provided, wherein the intermediatecollateral device may associate with, or in a non-limiting embodiment,be attached to the medicament device. The intermediate collateral devicemay include a sensor and/or a transmitter in a non-limiting embodiment.The intermediate collateral device may be configured to communicate(i.e., communicatingly connects) either wirelessly or by wiredconnection with the medicament device, a collateral device, and/or aremote device. The communication may include one-way communication to orfrom the intermediate collateral device, or two-way communication therebetween. The communication may include a communication of power orinformation, including a communication of signals there between. Inalternative non-limiting embodiments, the intermediate collateral devicemay be attached to a collateral device or a remote device.

Embodiments of the systems and devices disclosed herein may furtherinclude a remote communication component, wherein the remotecommunication component is configured to provide communication betweenthe medicament system and/or the user and a remote source. Thecommunication component may be used by a remote source (or entity) tocontact the system and/or the user of the system or retrieve informationtherefrom or send information thereto. The communication component mayalso, or alternatively be used by the user of the system to access aremote source (or entity) to communicate therewith, receive informationfrom and/or send information to. In non-limiting embodiments, the remotesource may include emergency personnel or other healthcare professional,a pharmacy personnel, a help personnel or system operator who may beable to answer questions regarding the device or system or receiveinformation there from, a computer or central network accessible forhelp using the system, for example, and/or a family member or otherperson, for example. The remote communication component may provideaccess to the user via the system to a remote source and/or provideremote source access to the system and/or the user.

Non-limiting embodiments of the system and device are provided in theFigures described herein. FIG. 1 provides a schematic view of amedicament system 100 comprising a medicament device 10 a and acollateral device 12 a. The medicament device 10 a comprises a housing14, which may include one or more mechanical components that may moverelative to one another during the use of the medicament device 10 a innon-limiting embodiments. For example, where the medicament device 10 aincludes a respiratory inhaler device or trainer, there may be one ormore mechanical components of the device that when moved relative to oneanother during use of the device makes signature clicking sounds. Theseclicking sounds can be observed by a user and may be indicative as towhether the device is being used correctly or incorrectly. Any of themedicament device embodiments described herein may include one or moremechanical components.

The collateral device 12 a of FIG. 1 further includes an informationdetecting component 16, an information sending and/or informationreceiving component 18 (the sending and receiving components may be twoseparate components in other non-limiting embodiments), a microprocessor20, a storage medium component 22, a power source 24, and a signaloutput component 26. The information receiving component 18 and/or theinformation detecting component 16 of the collateral device 12 a may beable to receive signals or information from and/or detect movement ofthe medicament device 10 a, or components thereof. This information maybe used to determine whether the medicament device is being used,whether it is being used correctly, and to provide any other informationabout the medicament device and/or from the medicament device 10 a tothe collateral device 12 a. The information detecting component 16 mayinclude a camera or a microphone, in non-limiting examples.

The information sending component of the collateral device 12 a may beused to send information or signals to the medicament device 10 a, in anon-limiting embodiment. The signal output component 26 of thecollateral device 12 a may be used to provide information and feedbackto a user of the system 100, in a further embodiment. This feedback maybe provided by any means known in the art, including but not limited to,by visual stimuli, audio, vibration, temperature change, gustatory andother types of feedback may also be used. Consequently, the signaloutput component may include a light or display, or a combinationthereof, and/or a speaker, in non-limiting embodiments. The storagemedium component 22 may be used to store information includinginstructions for using the medicament device 10 a in an embodiment, andmore specifically, stepwise instructions in a further embodiment. Thestorage medium component 22 may further include information about,instructions for use of multiple medicament devices among otherinformation stored thereon. This information may be stored on thestorage medium component 22 and may be pre-loaded and/or retrieved bythe system 100 in non limiting embodiments.

In another embodiment, a medicament system 200 is shown in the schematicview of FIG. 2, including a medicament device 10 b having a housing 14,a collateral device 12 b communicatingly connected to the medicamentdevice via wired or wireless connection (wireless RFID connection shownin FIG. 2). The wireless RFID (Radio Frequency Identification)connection is shown in FIG. 2, wherein the RFID transponder 30 isassociated with the medicament device 10 b, and the RFID reader 32 isassociated with the collateral device, however, in other embodiments theRFID components may be associated with other devices of the systemand/or the RFID transponder 30 may be associated with the collateraldevice 12 b and the reader 32 associated with the medicament device 10b, in non-limiting examples. Information and signals may be communicatedbetween the RFID transponder 30 and the RFID reader 32 between thedevices of the system 200 as described herein. Power can also becommunicated or transmitted there between as aforementioned.Communication of information, signals and/or power may include two-waycommunication or one way communication from one component to anothercomponent of the system 200 in non-limiting embodiments, as describedabove. Communication of information can also or alternatively beprovided by way of Bluetooth connection 34 as shown in the non-limitingembodiment of FIG. 2. The medicament device 10 b may further include asensor 28, and a transmitter 36 to send a signal from sensor inputs, forexample, to the collateral device 12 b. The collateral device 12 b mayinclude an information detecting component 16, an information receivingcomponent 18, a signal output component 26, a storage medium component22, a microprocessor 20, and a power source, in on-limiting embodiments.The collateral device may also include an information sending componentto send information to the medicament device 10 b, in a non-limitingembodiment.

Embodiments of the system described herein, such as, in a non-limitingexample, the system of FIG. 2 provide communication between a medicamentdevice 10 b and a collateral device 12 b, wherein the collateral devicemay include a Smartphone or other such device which may include some ofthe various components described.

Embodiments of the medicament system provided herein, for example, as inFIG. 2 may be used to train a user to use the medicament device, whereinfeedback about a use of the device, about a medicament, or about a user,for example, may be provided by the collateral device. Furthermore, themedicament system embodiments may be used to guide a user to delivermedicament or train a user to use a medicament device, wherein the useris a training-only or training and deliver device, by providing feedbackto the user on the collateral device 12 b, in a non-limiting embodiment.Consequently the connection between the medicament device 10 b and thecollateral device 12 b can provide a communication of information suchthat the collateral device 12 b may be used to communicate informationabout the medicament device 10 b or a user thereof to the user, innon-limiting embodiments.

In a further embodiment, a medicament system embodiment 300 is providedin FIG. 3, wherein a medicament device 10 c including a housing 14 isconfigured to be attached to a collateral device 12 c (or vice versa,the collateral device 12 c may be configured to be attached to amedicament device 10 c) by way of an attachment component 38, in anon-limiting embodiment. The collateral device 12 c may include a sensor28, a signal output component 26 to communicate and provide feedback toa user, a microprocessor 20 to process signals received from the sensor28 in anon-limiting embodiment, a storage medium component 22, and apower source 24 to provide power to the collateral device 12 c and, infurther non-limiting embodiments, to the medicament device 10 c by wayof wired or wireless connections as described herein. In the medicamentsystem embodiment 300, the medicament device 10 c may have, but need notinclude any components, wherein all the system components may be in thecollateral device 12 c. Information can be sensed by and/or received bythe collateral device 12 c from the medicament device 10 c (and in someembodiment sent to the medicament device 10 c from the collateral device12 c), via the attachment between the collateral device 12 c andmedicament device 10 c through the attachment component 38.

In still a further embodiment of the medicament system 400 shown in FIG.4, the medicament device 10 d and the collateral device 12 d may beconfigured to be attached to one another by way of an attachmentcomponent 38. The collateral device 12 d may include a sensor 28, andthe medicament device may include a housing 14, a microprocessor 20, astorage medium component 22, power source 24, and signal outputcomponent 26. In this embodiment the power source may be used to powerthe collateral device 12 d by way of a wired or wireless connectionbetween the medicament device 10 d and collateral device 12 d.

In yet a further embodiment of the medicament system 500 shown in theschematic of FIG. 5, a medicament device 10 e having a housing 14 and anintermediate collateral device 138 are configured to be attached to oneanother by way of an attachment component 38. The intermediatecollateral device 138 may include a sensor 28 to sense information aboutthe intermediate collateral device 138 and therefore, the medicamentdevice 10 e by way of its attachment thereto. Sensor information caninclude location information, position, orientation, among otherinformation as described herein that can be sensed by one or moresensors of the system. The medicament system embodiment 500 may furtherinclude a collateral device 12 e, which may include other components ofthe system such as, for example, the signal output component 26, theinformation detecting component 16, information receiving componentand/or sending component 18, microprocessor 20, storage module 22,and/or power source 24, in a non-limiting embodiment. The collateraldevice 12 e may be associated with the intermediate collateral device138 by way of a wired and/or a wireless connection as described herein,for example, by a Bluetooth® connection 34. Furthermore, in a furthernon-limiting embodiment, the collateral device 12 e may connectwirelessly or by wired connection with the medicament device 10 e.

In yet a further embodiment of the medicament system 600 shown in FIG.6, a medicament device 10 f may be associated with an intermediatecollateral device 138. The association between the medicament device 10f and the intermediate collateral device 138 may include a wired or awireless connection, or may include an attachment component 38 as shownin FIG. 6. The intermediate collateral device 138 may further becommunicatingly connected to a collateral device 12 f. The collateraldevice 12 f may be further communicatingly connected to a remote device40. The connections between the devices of the system 600 may includewired or wireless connection as described herein, the wirelessconnection including but not limited to RFID or Bluetooth® connection.The remote device 40 may include a database to which information can beuploaded to from the system 600 or downloaded from to the system 600.The remote device 40 may further include another device, a computer, atelephone, a smart device, or a watch, among other devices. Thesedevices may allow other persons or entities to send information to thesystem 600, retrieve information from or receive information from thesystem 600, in non-limiting embodiments. Additionally, in the embodimentof 600, the intermediate collateral device 138 or the medicament device10 f may be configured so as to send information to or receiveinformation from the remote device 40, by either wired or wirelesscommunication as discussed herein.

It should be borne in mind that all patents, patent applications, patentpublications, technical publications, scientific publications, and otherreferences referenced herein are hereby incorporated by reference inthis application in order to more fully describe the state of the art towhich the present invention pertains.

It is important to an understanding of the present invention to notethat all technical and scientific terms used herein, unless definedherein, are intended to have the same meaning as commonly understood byone of ordinary skill in the art. The techniques employed herein arealso those that are known to one of ordinary skill in the art, unlessstated otherwise. For purposes of more clearly facilitating anunderstanding the invention as disclosed and claimed herein, thefollowing definitions are provided.

While a number of embodiments of the present invention have been shownand described herein in the present context, such embodiments areprovided by way of example only, and not of limitation. Numerousvariations, changes and substitutions will occur to those of skill inthe art without materially departing from the invention herein. Forexample, the present invention need not be limited to best modedisclosed herein, since other applications can equally benefit from theteachings of the present invention. Also, in the claims,means-plus-function and step-plus-function clauses are intended to coverthe structures and acts, respectively, described herein as performingthe recited function and not only structural equivalents or actequivalents, but also equivalent structures or equivalent acts,respectively. Accordingly, all such modifications are intended to beincluded within the scope of this invention as defined in the followingclaims, in accordance with relevant law as to their interpretation.

While one or more embodiments of the present invention have been shownand described herein, such embodiments are provided by way of exampleonly. Variations, changes and substitutions may be made withoutdeparting from the invention herein. Accordingly, it is intended thatthe invention be limited only by the spirit and scope of the appendedclaims. The teachings of all references cited herein are incorporated intheir entirety to the extent not inconsistent with the teachings herein.

What is claimed is:
 1. A medicament system configured to communicateinformation about a medicament device or about a use of a medicamentdevice, or a combination thereof, to a user, said medicament systemcomprising: a medicament device comprising a housing and a mechanismcomprising one or more mechanical components that move relative to oneanother to produce a vibration or mechanical sound during use; and acollateral device to provide information to a user during use of themedicament device, said collateral device comprising (a) a vibrationsensor, a microphone, or a combination thereof to sense the vibration ormechanical sound; (b) a microprocessor; (c) a signal output component;(d) a storage module component; and (e) an additional sensor thatdetects removal or placement of the medicament device onto the user;wherein the collateral device is configured to (i) determine whether thevibration or mechanical sound relates to a condition of the medicamentdevice, (ii) to detect a condition of the medicament device based oninformation sensed by the vibration sensor and/or microphone and theadditional sensor, and (iii) to provide feedback to the user based onthe detected condition.
 2. The medicament system of claim 1, wherein thecondition is an error condition.
 3. The medicament system of claim 2,wherein the error condition is incorrect positioning or contact betweenthe device and the user.
 4. The medicament system of claim 2, whereinthe error condition is an out of sequence operation of the medicamentdevice.
 5. The medicament system of claim 4, wherein the out of sequenceoperation is a wet injection.
 6. The medicament system of claim 1,further comprising an attachment component for attaching the collateraldevice to the medicament device.
 7. The medicament system of claim 1,wherein the additional sensor comprises a contact sensor, proximitysensor, tilt sensor or perpendicularity sensor.
 8. The medicament systemof claim 1, wherein said signal output component is configured to outputan audio, a visual, a tactile, a gustatory, or an olfactory signal, or acombination thereof, to the user.
 9. The medicament system of claim 1,wherein the collateral device comprises a Smartphone.
 10. The medicamentsystem of claim 1, wherein the collateral device comprises a powersource.
 11. The medicament system of claim 1, wherein the collateraldevice further comprises a camera and/or a motion sensor.
 12. Themedicament system of claim 11, wherein the camera is configured toreceive a signal from the medicament device, said signal providesinformation about the medicament device, a medicament associated withthe device, and/or a use of the medicament device.
 13. The medicamentsystem of claim 1, wherein the medicament device is a medicamenttraining device, a medicament delivery device, or a combination thereof.14. The medicament system of claim 1, wherein the collateral device isconfigured to download or receive information from a database, theInternet, and/or another device, said information comprises informationabout a medicament, a medicament device including instructions for use,contraindication of medicaments, information about a user, medicamentdosage information, storage information, prescribing physicianinformation, pharmacy information, manufacturer information, warninginformation, recall information, environmental data, geographicalinformation, time zone information, MET (meteorological) data, storageinformation, supply chain information, transit data, and/or temperaturedata.
 15. The medicament system of claim 1, wherein the signal outputcomponent comprises a speaker, a display, a light, a vibrationcomponent, a smell-emitting component, or a temperature-changingcomponent, or a combination thereof.
 16. The medicament system of claim1, wherein the storage module comprises pre-programmed information abouta medicament device and/or instructions for use for a medicament deviceand/or a medicament associated therewith.
 17. The medicament system ofclaim 1, wherein the attachment component comprises: a hook, a clip, amagnet, or a holder which may be contoured to receive the medicamentdevice, or a combination thereof.
 18. A medicament system configured tocommunicate information about a medicament device or about a use of amedicament device, or a combination thereof, to a user, said medicamentsystem comprising: a medicament device comprising a housing and amechanism comprising one or more mechanical components that moverelative to one another to produce a vibration or mechanical soundduring use; and a collateral device to provide information to a userduring use of the medicament device, said collateral device comprising(a) a vibration sensor, a microphone, or a combination thereof to sensethe vibration or mechanical sound; (b) a microprocessor; (c) a visualsignal output component; (d) a storage module component; and wherein thecollateral device is configured to determine whether the vibration ormechanical sound relates to a condition of the medicament device.